Services

We offer a comprehensive range of services to Principal Investigators, Clinical Research Staff and Study Sponsors, from the early stages of protocol development through to study delivery and closure. We support Clinical Study Teams at our local site, Children’s Health Ireland (CHI) at Crumlin, as well as other paediatric hospitals across Ireland.

As well as supporting sites to participate in multi-centre studies, we also operate at a study level, providing a central multi-centre trial management service.

We operate a paediatric feasibility service fielding new study feasibility queries and connecting Study Sponsors with potential Investigators. This includes:

Assisting with the identification of Principal Investigators

Coordinating the sign-off of Confidential Disclosure Agreements

Supporting Investigators to complete study feasibility assessments

In addition to the existing NCRC’s network of collaborators, in 2015 we embarked on a formal partnership with PPD, a leading global contract research organization, to establish a Paediatric Investigator Network (PIN). The PIN is made up of over 60 Paediatricians from across Ireland, and is one of a global network of 12 partnerships to connect study sites with clinical study sponsors.

Each study is assigned a dedicated Study Coordinator to guide Investigators and Clinical Teams through study set-up, conduct and closedown. According to the individual study requirements, this may be a Clinical Research Coordinator or Research Nurse. Support may also be provided by a Research Assistant.

The Study Coordinator’s responsibilities include:

Serving as the key operational contact between Study Sponsor, the Investigator and Clinical Study Team

Coordination of study site activities including patient study visits and monitoring visits

Investigator Site File management

Data collection, data entry and query management

Reporting of Adverse Events including Serious Adverse Events according to study timelines

The main purpose of the research pharmacy service is to maintain control and accountability of investigational medicinal products (IMPs) and non-investigational medicinal products (NIMPs).

The role of pharmacy in relation to clinical research is to safeguard subjects, healthcare professionals and the hospital ensuring that IMPs and NIMPs are appropriate for use and are procured, handled, stored and used safely and correctly.

The CCRU has a dedicated Clinical Trials Pharmacist to ensure that IMPs/NIMPs are managed and dispensed to patients in accordance to approved protocols and ensures that all pharmacy clinical trial procedures comply with all relevant guidelines and regulations.

A Quality Management System (QMS) based upon Good Clinical Practice (ICH GCP) Guidelines and all applicable regulatory and ethical requirements is in place to ensure that all research supported by the CCRU is conducted to the highest standards of research and clinical governance. Consisting of policies, standard operating procedures and internal auditing and quality control measures, it ensures that the highest standard of excellence and safety in treating children and young adults is achieved.

The training is targeted towards Investigator and Site Research Staff working on clinical trials of investigational medicinal products.

These trainings meet the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma, as necessary to enable mutual recognition of GCP training among trial sponsors.

They have also been granted Continuing Professional Development (CPD) course Category 1 Approval by the Nursing and Midwifery Board of Ireland.

Courses are generally located at the NCRC/CHI at Crumlin but we are also available to provide training at other locations on request.

Scheduled dates for 2019

Introduction to Paediatric Clinical Research & Good Clinical Practice (GCP) – Full day course

10th April 2019

12th June 2019

27th September 2019

Paediatric Good Clinical Practice (GCP) Refresher – Half day course

17th July 2019

29th November 2019

Both courses are accredited by the Nursing & Midwifery Board of Ireland (NMBI) – 6 CEUs and 3 CEUs, respectively. They also meet the minimum criteria for ICH GCP investigator site personnel training identified by TransCelerate Biopharma as necessary to enable mutual recognition of GCP training among trial sponsors.

For further information or to book a place on one of the upcoming courses, please contact gcptraining@ncrc.ie.

Additional dates can also potentially be facilitated at alternative locations for groups of 10 or more.